Evolution and Risk Factors Associated With Geographic Atrophy Progression

NCT01694095 | Completed DMC

• 1 other identifier: GAIN-002-10-2010
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. The aims of this study are to describe the natural history of geographic atrophy and identify potential risk factors associated with a faster spread of atrophy that may be used to develop rational therapies.

Conditions

Geographic Atrophy

Keywords

Geographic atrophy, prognosis, risk factors, natural history

Outcome Measures

Primary Outcomes (1)

• Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2

  For measures related to change in the area of atrophy, a multivariable model will be fit and will include as an independent variable (amongst other presumed risk factors) fundus autofluorescence patterns

  From baseline to last follow-up

Secondary Outcomes (1)

• Median change in area of geographic atrophy as measured in square root of mm2 with fundus autofluorescence on a 30º image centered on field 2

  From baseline to last follow-up

Other Outcomes (3)

• Median/mean change in best-corrected visual acuity as measured with an Early Treatment Diabetic Retinopathy Study chart

  From baseline to last follow-up

• Percentage of eyes developing new choroidal neovascularization in the study eye as evaluated with fluorescein angiography and spectral-domain optical coherence tomography

  From baseline to last follow-up

• Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2

  From baseline to last follow-up

Study Arms (1)

Patients with geographic atrophy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with geographic atrophy

You may qualify if:

• Both sexes
• years of age or older
• Uni or bilateral areas of geographic atrophy in the macula (as defined as areas devoid of retinal pigment epithelium measuring at least 0.5 disk areas on a 35º fundus photograph centered on field 2) secondary to age-related macular degeneration
• Willing to provide Informed consent

You may not qualify if:

• Other causes of geographic atrophy aside from age-related macular degeneration (ie, drug induced, central serous chorioretinopathy)
• Prior history of wet age-related macular degeneration
• Other significant concomitant macular diseases (ie, significant epiretinal membrane, stage II-IV macular hole)
• Previous treatment with macular laser photocoagulation, photodynamic therapy, antiangiogenic drugs or other treatments for wet age-related macular degeneration
• Intraocular surgery aside from phacoemulsification
• Inability to measure the full extent of the area of atrophy on a 35º fundus autofluorescence image centered on field 2
• Areas of geographic atrophy in direct contact with peripapillary areas of atrophy

Sponsors & Collaborators

• Institut de la Macula y la Retina: lead

Study Sites (1)

Institut de la màcula i de la retina

Barcelona, Barcelona, 08017, Spain

Location

Related Publications (4)

• Biarnes M, Mones J, Trindade F, Alonso J, Arias L. Intra and interobserver agreement in the classification of fundus autofluorescence patterns in geographic atrophy secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):485-90. doi: 10.1007/s00417-011-1846-y. Epub 2011 Oct 28.

  PMID: 22033626 RESULT

• Mones J, Biarnes M, Trindade F. Hyporeflective wedge-shaped band in geographic atrophy secondary to age-related macular degeneration: an underreported finding. Ophthalmology. 2012 Jul;119(7):1412-9. doi: 10.1016/j.ophtha.2012.01.026. Epub 2012 Mar 21.

  PMID: 22440276 RESULT

• Mones J, Biarnes M, Trindade F, Arias L, Alonso J. Optical coherence tomography assessment of apparent foveal swelling in patients with foveal sparing secondary to geographic atrophy. Ophthalmology. 2013 Apr;120(4):829-36. doi: 10.1016/j.ophtha.2012.09.054. Epub 2013 Jan 3.

  PMID: 23290986 RESULT

• Biarnes M, Forero CG, Arias L, Alonso J, Mones J. Reappraisal of geographic atrophy patterns seen on fundus autofluorescence using a latent class analysis approach. Invest Ophthalmol Vis Sci. 2014 Nov 18;55(12):8302-8. doi: 10.1167/iovs.13-13542.

  PMID: 25406275 RESULT

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jordi Monés, MD, PhD

  Institut de la màcula i de la retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 22, 2012
• First Posted: September 26, 2012
• Study Start: December 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ES (1)